FDA |
Treatment of patients with CLL with del(17p) who have been treated with at least one prior therapy [51] |
Monotherapy |
Treatment of patients with CLL who have received at least one prior therapy [32] |
2 years fixed duration, combined with rituximab |
Treatment of patients with previously untreated CLL [31] |
1 year fixed duration, combined with obinutuzumab |
Treatment of patients with newly diagnosed AML who are ≥ 75 years old or ineligible for intensive induction due to comorbidities [151, 152] |
Combined with azacytidine, decitabine or lose-dose cytarabine |
EMA |
Treatment of patients with CLL with del(17p) or TP53 mutation who are unsuitable for or have failed a B cell receptor pathway inhibitor [51] |
Monotherapy |
Treatment of patients without del(17p) or TP53 mutations who have failed both chemo-immunotherapy and a B cell receptor pathway inhibitor [55, 56] |
Monotherapy |
Treatment of patients with CLL who have received at least one prior therapy [32] |
2 years fixed duration, combined with rituximab |
Treatment of patients with previously untreated CLL [31] |
1 year fixed duration, combined with obinutuzumab |
Treatment of patients with newly diagnosed AML who are ineligible for intensive chemotherapy [151] |
Combined with a hypomethylating agent |